BD (Becton, Dickinson and Company) Quality Compliance Lead in BD Research Centre Ireland (inactive), Ireland
Job Description Summary
BD is recruiting a Quality Compliance Lead to provide quality compliance support to the Worldwide Infusion Specialty Disposables (WWISD) portfolio of products. You will be responsible for overseeing and participating in day-to-day compliance activities relating to product situation analysis, notification and evaluation of incidents, competent authority inquiries and follow up, field actions and Quality Management System process integration and alignment. You will proactively address WWISD compliance needs for products and processes in EMEA and other geographies outside the U.S. (as applicable).
As Quality Compliance Lead , you will,
Lead the resolution of current WWISD compliance issues as assigned by the Senior Director EMEA Quality Compliance
Support integration of new business acquisition processes and procedures into the existing BD model; identify and implement optimization opportunities
Manage relationships with competent authorities, ensuring deliverables and timelines are met
Assess reported events to determine regulatory reportability; prepare vigilance/regulatory reports as well as communications to Competent Authorities, as required
Liaise with and support US colleagues regarding US FDA reporting for products holding US FDA 510(k) clearance
Work with business leaders on identified projects and support key business goals and objectives
Participate in the preparation and execution of FSCA/FSN for impacted products
Escalate high-priority issues as well as identified business risks to the Senior Director EMEA Quality Compliance and other relevant management
Support and participate in audits performed by internal and external (e.g. Notified Body) representatives
Represent WWISD Quality at scheduled risk management and business meetings
The successful candidate will be educated to degree level in a Science related area or equivalent experience and have demonstrated clinical knowledge and experience in medical device and QA and/or RA, preferably in compliance-based roles. You will have an in-depth knowledge of European Medical Device Directive and the new Medical Device Regulation, experience in Adverse Event handling in accordance with applicable MEDDEV and FDA guidance as well as other European/Emerging Market/international geography regulatory requirements for post market activities. You will have demonstrable experience dealing with competent authorities and other regulatory bodies. You will have project management and/or process change (process improvement) experience with the ability to simultaneously work on multiple projects/activities of various disciplines.
You will have the ability to critically think, solve problems (i.e. solution seeker) and meet deadlines. You will have a conscientious, detail-orientated approach to work
If you’re a team player who is passionate about manufacturing and ‘advancing the world of health’ and we’ve just described your career aspirations, then please APPLY.
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Join our talent community here. emea.jobs.bd.com
Primary Work Location
GBR Winnersh - Eskdale Road
IRL - BD Research Centre Ireland (inactive)
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.